Economic Outcomes of EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) in T2D Patients Who Are New to Injectable Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15498 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-15

Study Completion Date

2016-12-15

Brief Summary

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Primary objective of this study is to compare diabetes-related healthcare utilization and costs in patients initiating exenatide once weekly vs insulin glargine.

Detailed Description

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This retrospective, observational cohort analysis will assess medical and pharmacy claims for adult patients with type 2 diabetes from the Truven Health MarketScan® Commercial and Medicare Supplemental claims databases between 2011 and 2015. Diabetes-related healthcare utilization and costs will be measured as a primary outcome. Secondary outcomes include all-cause healthcare utilization and costs, major adverse cardiovascular event (MACE)-related utilization and costs, and medically attended hypoglycemia events.

Conditions

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Diabetes Mellitus Type 2

Keywords

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Diabetes Mellitus Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Exenatide once weekly (EQW)

EQW cohort includes patients with one or more outpatient prescription claims for EQW between 2012 and 2015.

No interventions assigned to this group

Insulin Glargine (IG)

IG cohort includes patients with one or more outpatient prescription claims for IG between 2012 and 2015

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. One or more outpatient prescription claim for EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) between February 1, 2012, and June 30, 2014 (date of first claim = index date; medication to which first claim corresponds = index therapy).
2. Aged 18 or older as of the index date.
3. Continuous enrollment in medical and pharmacy benefits for 12 months before (baseline period) and 12 months after (follow-up period) the index date. (6 months follow-up will be provided to determine the effect on sample size.)
4. One or more medical claims with a diagnosis code for T2DM (ICD-9-CM 250.x0 or 250.x2) in the baseline period or on the index date.

Exclusion Criteria

1. No outpatient prescription claims for any injectable glucose-lowering medication during the baseline period (GLP-1RA or insulins).
2. No medical claims with a diagnosis (or procedure, where appropriate) code indicative for type 1 diabetes mellitus (ICD-9-CM 250.x1 or 250.x3), gestational diabetes (ICD-9-CM 648.8x), or pregnancy or childbirth in the baseline or follow-up periods.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric T. Wittbrodt, PharmD, MPH

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research site

Wilmington, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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D5551R00012

Identifier Type: -

Identifier Source: org_study_id